Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-0823

2. Registrant Information.

Registrant Reference Number: 2020-CA-000432

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G 5L3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

28-DEC-20

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

27-DEC-20

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

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PMRA Registration No. 28382      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Spray for Cats and Kittens

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .27 %
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • Guarantee/concentration .62 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration .37 %
  • PYRETHRINS
    • Guarantee/concentration .2 %

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Foaming at mouth

• Cardiovascular System
  • Symptom - Tachycardia

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On 27-Dec-2020 the animal owner applied the product topically to the cat. At an unspecified time later on 27-Dec-2020 the cat developed symptoms. Cat was receiving unspecified treatments by a veterinarian at the time of the report. Limited information available and further information is not expected.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here

Assessment: This product has a wide margin of safety. If ingested, hypersalivation may occur due to a taste reaction and GI irritation may develop. Tachycardia can develop in some cats due to stress from either the taste reaction or transport and treatment at the veterinary clinic. Life-threatening symptoms are not expected. Further information about treatment performed may provide additional clarity but is not available. Underlying disease should be ruled out. The information contained in this report is based on self-reported statements provided to the registrant via email. These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the email.